Kornimate/medical-research-clean huggingface dataset:
study of the effects of commercial air travel on the lungs

Conditions: Healthy Volunteers; Chuvash Polycythaemia

Summary: the study hypothesis is that commercial air travel causes an increase in the blood pressure in the lungs (pulmonary artery pressure) that can be clinically relevant. portable echocardiography (heart ultrasound) now offers a non-invasive means of studying this in-flight.

in a commercial airliner flying at high altitude, the reduced cabin air pressure means that all passengers are exposed to slightly lowered oxygen levels ('hypoxia') equivalent to an altitude of approximately 5,000 to 8,000 ft. although mild, this hypoxia is sufficient to stimulate some of the body's protective responses (eg changes in breathing and in hormonal secretion) and can be dangerous for passengers with heart or lung disease, who must breathe supplementary oxygen in-flight or may even be prohibited from flying because of the risks of hypoxia. it is well known that severe hypoxia results in constriction of blood vessels in the lungs (a phenomenon called hypoxic pulmonary vasoconstriction), which in turn causes an increase in the blood pressure in the lungs ('pulmonary arterial pressure'). unlike other physiological responses to hypoxia, this is often harmful and frequently leads to pulmonary hypertension and right heart failure (eg in some lung diseases and at high altitude). even a modest increase in pulmonary arterial pressure could be clinically important in some airline passengers with heart/lung disease, as it may exacerbate their condition. however, it is not known whether the mild hypoxia experienced in an aircraft cabin is able to cause an increase in pulmonary artery pressure. limited evidence suggests that it might - for example, there have been reports of passengers acutely developing new right heart failure in-flight, and data from animal studies also support this possibility. this study aims to establish the effect of mild aircraft cabin hypoxia on pulmonary arterial pressure in healthy passengers and also in a patient with chuvash polycythaemia. in this rare genetic disease, cellular responses to hypoxia are 'switched on' to some extent even during normoxia, causing increased red blood cell production. affected individuals usually present with symptoms of polycythaemia in early adulthood and are typically asymptomatic following treatment with therapeutic venesection. importantly, affected individuals have exaggerated acute hypoxic pulmonary vasoconstriction which may place them at risk of pulmonary hypertensive responses during air travel.

Eligibility criteria:
for healthy volunteers: inclusion criteria: * suitable for echocardiographic measurements * in good health exclusion criteria: * any significant medical condition for patient with chuvash polycythaemia: inclusion criteria: * diagnosis of chuvash polycythaemia * suitable for echocardiographic measurements exclusion criteria: * any other significant medical condition * pulmonary hypertension * uncontrolled erythrocytosis

Keywords: air travel aircraft cabin hypoxia pulmonary artery pressure hypoxic pulmonary vasoconstriction pulmonary hypertension
treating late-life generalized anxiety disorder (gad) in primary care

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to determine whether cognitive behavior therapy (cbt) is effective in the treatment of generalized anxiety disorder (gad) in adults age 60 and older in a primary care setting.

generalized anxiety disorder (gad) is one of the most common anxiety disorders among older adults. anxiety in older adults is associated with decreased physical activity, poorer self-perceptions of health, decreased life satisfaction, and increased loneliness. because many older adults with anxiety seek assistance in a medical setting, treatment has been primarily pharmacological. there is, however, limited evidence of the effectiveness of psychotropic medications. given the potential difficulties in prescribing psychotropic medications in later life (e.g., increased adverse effects, potential drug interactions), psychosocial treatments may be important alternative or adjuncts. the treatment phase of this study lasts 10 weeks, during which patients will be randomly assigned to either cognitive behavior therapy (cbt) or usual care. follow-up will last 12 months after treatment completion, during which time patients will complete telephone assessments.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of generalized anxiety disorder exclusion criteria: * active suicidal intent * current psychosis * current bipolar disorder * substance abuse within past month * cognitive impairment

Keywords: generalized anxiety disorder geriatric
study of milnacipran for the treatment of fibromyalgia

Conditions: Fibromyalgia

Summary: antidepressants of all varieties represent a common form of therapy for many chronic states including fibromyalgia. the majority of antidepressants increase the levels of serotonin or norepinephrine in the central nervous system. milnacipran is a dual norepinephrine and serotonin reuptake inhibitor and may be effective in the treatment of fibromyalgia.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia defined by 1990 american college of rheumatology (acr) criteria exclusion criteria: * psychiatric illness * depression * suicidal risk * substance abuse * pulmonary dysfunction * renal impairment * active cardiac disease * liver disease * autoimmune disease * cancer * sleep apnea * inflammatory bowel disease

Keywords: nsri milnacipran fibromyalgia
efficacy and safety of ranibizumab 0.5 mg administered as two alternative dosing regimens in chinese patients with namd (age related macular degeneration)

Conditions: Neovascular Age-related Macular Degeneration

Summary: the study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in chinese patients with wet age-related macular degeneration (amd) . this study was to provide long-term safety data in the treatment of chinese patients with wet amd.


Eligibility criteria:
key inclusion criteria: * patients with visual impairment due to neovascular amd * a qualifying vision score at study entry key exclusion criteria * active infection or inflammation either eye at study entry * uncontrolled glaucoma in either eye * any disorder in the study eye which may affect vision * use of any systemic anti-vascular endothelial growth factor (vegf)-drugs within 3 months prior to study entry * previous treatment of the study eye for wet amd * any surgery in the study eye 3 months prior to or planned with 6 month after study entry

Keywords: macular degeneration, age-related macular degeneration (armd), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, amd
renal: tnf-alpha inhibitor for improving renal dysfunction and primary graft dysfunction after lung transplant

Conditions: Lung Transplant; Complications

Summary: the purpose of this study is to assess whether tnfa antibody use before lung transplant can prevent kidney injury after lung transplant.

after being informed about the study and potential risks, all patients giving written consent who undergo a lung transplant will be randomized in a 1:1 ratio to either the treatment or control group. patients randomized to the treatment group will receive one dose of the study drug, etanercept, via subcutaneous injection just prior to the lung transplant. patients randomized to the control group will not receive etanercept. both groups will receive standard lung transplant care after implantation.

Eligibility criteria:
inclusion criteria: * planning to undergo transplantation of the lung at northwestern memorial hospital. * willing and able to read, understand, and be capable of giving informed consent. exclusion criteria: * previous or current use of tnfa antibody. * any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating.
dehydroepiandrosterone (dhea) in systemic lupus erythematosus (sle) for coronary artery disease (cad) prevention

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to evaluate the effect of dhea on endothelial dysfunction in patients with systemic lupus by measuring: 1. changes in brachial artery flow-mediated dilatation (fmd) and 2. changes in biomarkers of cardiovascular risk. patients will be enrolled in a randomized, double-blinded crossover trial of dhea or placebo for ten weeks, then crossed over to the alternate treatment arm after a six-week washout period. hypothesis: dehydroepiandrosterone (dhea) administration in premenopausal women with sle modifies cardiovascular risk by improving vascular endothelial function and other biomarkers associated with cardiovascular heart disease.


Eligibility criteria:
inclusion criteria: * female * member of the michigan lupus cohort * meet the american college of rheumatology (acr) criteria for sle * premenopausal exclusion criteria: * smoker * diabetic * prednisone dose \> 10 mg

Keywords: systemic lupus erythematosus dehydroepiandrosterone (dhea) dhea sle lupus
screening for silent atrial fibrillation during influenza vaccination

Conditions: Atrial Fibrillation

Summary: silent atrial fibrillation is an important cause of unnecessary strokes. if diagnosed and treated in time with anticoagulants, many disabling strokes can be prevented. in order to improve the diagnosis of atrial fibrillation the mydiagnostick is developed; a user friendly and easy to use stick that diagnoses atrial fibrillation in one minute. during influenza vaccination, many patients who are also at risk for atrial fibrillation visit the general practice. this offers an ideal opportunity for screening for atrial fibrillation. the study investigates the yield of screening for atrial fibrillation with the mydiagnostick during influenza vaccination (newly detected atrial fibrillation with corresponding cha2ds2-vasc score).


Eligibility criteria:
inclusion criteria: * eligible for influenza vaccination exclusion criteria: * not eligible for influenza vaccination

Keywords: silent atrial fibrillation primary care screening influenza vaccination
the clinical trial for primary chronic venous insufficiency

Conditions: Primary Chronic Venous Insufficiency

Summary: a multicenter random clinical trial to confirm the advantage of the valve reconstructive surgery on primary chronic venous insufficiency.


Eligibility criteria:
inclusion criteria: * pcvi patients with iii degree back flow in deep vein that is confirmed by color doppler or phlebography exclusion criteria: * age over 70 years old * pregnancy * patients with severity arteriosclerosis obliterans, malignancy, severity disease of heart, lung or brain, and hematopathy

Keywords: primary chronic venous insufficiency surgery reconstruction valve
comparison between auto cpap and fixed cpap in chinese patients with osa

Conditions: Obstructive Sleep Apnea

Summary: autocpap would lead to better compliance than fixcpap

a prospective, randomized crossover cohort. study subjects consisted of patients newly diagnosed with obstructive sleep apnea (osa) confirmed with sleep study. all are cpap naïve. randomization: arm 1: auto cpap sleep study then auto cpap for 2 months arm 2: fixed cpap titration then fixed cpap for 2 months then switch over to the other arm trial end after 4 months, compliance and other parameters would be compared between two arms as described in the endpoint session.

Eligibility criteria:
inclusion criteria: * all subjects should be cpap naïve. * osa confirmed with sleep study * presence of daytime symptoms with excessive daytime sleepiness * age between 18 to 65 * rdi greater than 30 * agreed to participate in trial with informed consent signed exclusion criteria: * patients not suitable to nasal cpap because of facial abnormality leading to poor mask fitting. * patients with known copd with type ii failure * patients with known heart failure. * patients with predominant central sleep apnea. * patients need bilevel positive airway pressure ventilation. * patients refusing to participate the trial. * patients have difficulty to follow up regularly. * patients with untreated or under treatment of hypothyroidism
efficacy of hipec in the treatment of patients with locally advanced gastric cancer

Conditions: Advanced Gastric Adenocarcinoma

Summary: the purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with d2 lymphadenectomy. it is a multicentric and randomised phase iii trial.


Eligibility criteria:
inclusion criteria: * 18 \< age ≤ 65 years old * male or non pregnant female * the eastern cooperative oncology group (ecog) status ≤ 2 * histologically diagnosed as t4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or ct scan) * have not received cytotoxic chemotherapy, radiotherapy or immunotherapy * white blood cells \> 4,000/mm3 * neutrophils ≥ 1,500/mm3 * platelets ≥ 100,000/mm3 * hemoglobin\>9g/l * alanine transaminase (alt) and aspartate aminotransferase (ast) \< or = 2.5 times upper limit of nominal (uln) * total bilirubin (tbil) \< 1.5 times uln * serum creatinine \< 1 times uln * having given written informed consent prior to any procedure related to the study exclusion criteria: * existence of macroscopic peritoneal implants * prior malignant tumors with detectable signs of recurrence or distant metastasis * poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50% * receiving other cytotoxic chemotherapy * high grade of intra-abdominal adhesions * contraindication to any therapy contained in this regimen specific to the study without given written informed consent

Keywords: gastric adenocarcinoma hipec paclitaxel oxaliplatin capecitabine
fibreoptic intubation with and without sellick´s maneuver

Conditions: Intubation Intraesophageal; Respiratory Aspiration of Gastric Contents

Summary: the goal of this study is to evaluate the effect of sellick´s maneuver, a firm pressure on the throat, just below the adams apple, to occlude the esophagus, in order to prevent aspiration of gastric contents, on intubation with a flexible fiberscope. the result of this study will be participate in the discussion of the importance of sellick´s maneuver.

the patients included in this study has volunteered after sufficient information, and must be asa-class i-ii, 18 years or more, and must not have indications for a rapid sequence induction. the patient will be intubated twice, with and without sellick´s maneuver. it is blinded to the intubating physician, in which order this pressure is applied. the outcomes measures will be time of intubation, oxygen saturation before and after intubation and a cormack scale graduation of the visibility of the vocal cords. the intubation will be failed, if it cannot be performed under 120 seconds, or if the patients desaturate to 95% or less.

Eligibility criteria:
inclusion criteria: * asa i-ii * informed consent to participate in the study * age 18 or older * predicted difficult airways exclusion criteria: * body mass index more then 35 * patients with an indication for a rapid sequence induction (reflux, hiatus herniation, gastric bypass)

Keywords: intubation sellick´s maneuver aspiration [e05.497.578]
compliance and tolerability of rivastigmine transdermal patch 10 cm² in patients with probable alzheimer's disease.

Conditions: Alzheimer's Disease

Summary: this study will evaluate compliance, tolerability, safety, efficacy and caregiver burden of rivastigmine patch 10 cm² treatment in people with alzheimer's disease (mmse 10-26) initiating therapy for the first time with a cholinesterase inhibitor, and in patients who were unresponsive to previous cholinesterase inhibitor treatment in a community setting.


Eligibility criteria:
inclusion criteria: * probable alzheimer's disease according to the nincds-adrda (national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association) and dsm-iv (diagnostic and statistical manual of mental disorders) criteria; * mmse score of ≥10 and ≤ 26; exclusion criteria: * bradycardia (beats per minute less than 50) * body weight less than 40 kg; * hypersensitivity to cholinesterase inhibitors. other protocol-defined inclusion/exclusion criteria may apply

Keywords: alzheimer's disease, rivastigmine, patch
perioperative aspirin response in patients undergoing vascular surgery

Conditions: Vascular Surgery Patient With PAD / Carotid Stenosis

Summary: reduced antiplatelet activity (low response (lr)/high on-treatment platelet reactivity (hpr)) of aspirin (alr) or clopidogrel (clr) is associated with an increased risk of thromboembolic events. the prevalence figures for low-responders reported in the literature vary widely and there have been few investigations in vascular surgery patients to date. the aim of this prospective monocentric study was to increase the evidence base on vascular surgery patients and to detect any changes in the response following vascular surgery procedures.

the activity of aspirin (acetylsalicylic acid, asa) and clopidogrel is measured by whole blood impedance aggregometry using a multiple electrode aggregometer (multiplate). the agonists used are arachidonic acid for aspirin and adenosine diphosphate (adp) for clopidogrel. vascular patients requiring treatment for peripheral artery disease (pad) and/or carotid stenosis are included in the study. to identify possible risk factors demographic data, concomitant medication, laboratory parameters, co-morbidities, severity of the condition and the type of procedure performed are documented. in addition, a follow-up aggregometry is performed after completion of the vascular procedure.

Eligibility criteria:
inclusion criteria: • vascular patients requiring treatment for peripheral artery disease (pad) and/or carotid stenosis are included in the study. exclusion criteria: * non-adherence to the antiplatelet medication * abnormal platelet count in patients, * current gastrointestinal disorders, * current infections, * serious concomitant medical conditions (such as recent gastrointestinal bleeding, cancer, severe cardiac or liver disorders) * known bleeding or coagulation disorders,
share for persons with chronic conditions and their family caregivers

Conditions: Chronic Health Conditions; Family Caregivers

Summary: share-cc is an intervention for families facing the challenges of chronic conditions. share-cc (support, help, activities, resources, and education) addresses the need for both members of a care dyad to be actively involved in current and future care planning. this intervention aims to increase knowledge of services, improve communication skills and well-being, and facilitate the understanding of care values and preferences in order to create a mutually agreed upon care plan. this intervention will be tested in a randomized control trial.

this project offers a unique and timely opportunity to evaluate the feasibility, acceptability, and efficacy of the share-chronic conditions psycho-social intervention. the project will adapt the share intervention, for use with dyads facing the challenges of chronic conditions. the six-session share-cc program will be implemented and evaluated using a randomized controlled trial with 240 participants in northern ohio, the san diego and san francisco bay areas in california, and new jersey. the share-cc intervention addresses the need for a structured approach that targets both members of a care dyad and empowers them to be actively involved in current and future care planning. it has great potential to not only improve psychosocial outcomes for families, but to also impact healthcare decision-making and utilization. persons with chronic conditions and their caregivers will be interviewed prior to (time 1) and after participating (approximately 4 months post-time 1) in the share-cc intervention or pwcc control group.

Eligibility criteria:
inclusion criteria: pwcc: * living in geographic area of organizations delivering service * living at home rather than in an institutional setting * have a family cg as defined below * confirmed diagnosis of at least one chronic illness (e.g., heart disease, diabetes, copd, arthritis, kidney disease, stroke, hiv-aids, etc.) * require assistance with two or more activities of daily living (e.g., shopping, managing medications, dressing) or receives help with complex medical care tasks (e.g., wound care, preparing special meals); and * short blessed error score between 0 and 6 demonstrating normal cognitive function. for cgs to be eligible • must be the pwcc's spouse/partner, adult child, in-law, grandchild, step-child, or other close family member who has or will have primary responsibility for providing assistance to the pwcc exclusion criteria: * out of geographic areas * a primary diagnosis of a neurocognitive disorder (e.g. alzheimer's disease or related dementia) * a mental health condition (e.g., schizophrenia, bipolar disorder, major depression) * a traumatic brain injury, * intellectual or developmental disability * individuals experiencing extreme difficulty adjusting and coping to the diagnosis * individuals in the terminal phase of a chronic condition (i.e., eligible for hospice).

Keywords: care planning care values and preferences
evaluation of lomecel-b™ injection in patients with hypoplastic left heart syndrome (hlhs): a phase iib clinical trial.

Conditions: Hypoplastic Left Heart Syndrome

Summary: the purpose of this study is to test whether lomecel-b™ works in treating patients with hypoplastic left heart syndrome (hlhs) and to gather additional information about the safety of lomecel-b. lomecel-b contains human mesenchymal stem cells (mscs) as the active ingredient. mscs are special cells in the body that are able to change into other types of cells, such as heart, blood, and muscle cells. mscs are found in various tissues of the body, such as the bone marrow, which is the spongy tissue inside of your bones. lomecel-b uses mscs from bone marrow of unrelated young healthy donors. these are called "allogeneic", and do not require donor matching to the patient.


Eligibility criteria:
inclusion: all participants must have hlhs (includes all types) requiring stage ii palliation (glenn or hemi-fontan operation). exclusion: 1. requirement for ongoing mechanical circulatory support immediately prior to stage ii palliation within 5 days 2. need for concomitant surgery for aortic coarctation or tricuspid valve repair or endocardial fibroelastosis (efe) resection or left ventricle recruitment procedures 3. undergoing the stage i (norwood) procedure that does not have hlhs 4. serum positivity for: human immunodeficiency virus (hiv); hepatitis b virus surface antigen (hbv bsag); and/or viremic hepatitis c virus (hcv). this criterion can be ascertained by one of three ways: 1. documented history of mother's testing conducted during pregnancy 2. documented history of participants testing. 3. if above documentation is not available blood will be obtained from participant at screening/baseline. 5. parent/guardian that is unwilling or unable to comply with necessary follow-up 6. unsuitability for the study based on the investigator's clinical opinion 7. known hypersensitivity to dimethyl sulfoxide (dmso) 8. presence of a pacemaker, or anticipated placement of a pacemaker, at the time of the stage ii palliation

Keywords: hypoplastic left heart syndrome pediatrics heart defects congenital cardiovascular diseases stem cells